Risks and Complications

Intragastric Balloons

Like all medical and surgical procedures, having an intragastric balloon can carry risks and can result in unpredictable complications. The relative risks and potential benefits need to be assessed on an individual basis and depend on factors such as your medical history and personal circumstances. This will be discussed with you by your doctor in detail prior to committing to any procedure.

Some of the potential risks associated with intragastric balloon therapy are outlined below.

Endoscopy Related Risks

Anaesthesia – The anaesthesia required for the procedure to implant, adjust or remove the intragastric balloon can have risks of complications, injury and in rare cases, death.

Aspiration – Regurgitation of stomach fluids or food into the lungs can occur during balloon implantation, adjustment or removal. This is unlikely, particularly if the pre-procedure diet is followed as instructed. If food is found in the stomach during a procedure, it will be aborted due to the risk of aspiration. Severe aspiration is very rare preventative measures are taken, however it can cause pneumonia, respiratory failure requiring the support of a breathing machine and death.

Bleeding – Significant bleeding after an endoscopic procedure is uncommon. Bleeding may occur during endoscopy or immediately afterwards. A blood transfusion may be required in these rare circumstances and perhaps a repeat endoscopy or surgery is needed to stop bleeding.

Stomach or Oesophageal Injury – Injury to the stomach or oesophagus is a rare complication that can cause life-threatening complications. In the rare instance that this may occur surgery, a hospital admission, fasting periods and antibiotics may be required.

Organ Failure – In very rare circumstances, organ failure may occur following intragastric balloon placement or adjustment. This may include failure of the kidney, heart, lungs or liver.

Admission to Hospital – In the unlikely event of a complication from the procedure or anaesthesia, a hospital admission may be required. In some cases, surgery may be necessary to treat a problem or complication caused from the intragastric balloon or procedure.

Deep Vein Thrombosis (DVT)/Pulmonary Embolism – Blood clots after endoscopic procedures are uncommon. Blood clots can form in the legs, or elsewhere, and break off and travel to the heart and lungs causing injury or death.

Other Complications – Allergic reactions, headaches, itching, medication side-effects, damage or irritation of the vein where intravenous medications were given, heartburn/reflux, anaesthetic complications, injury to the bowel or vessels, gas and bloating

Death – The mortality rate following complications of the gastric balloon procedure is low, estimated at less than 1 in 10,000.

Intragastric Balloon Related Risks

Post-Procedure Symptoms – These are common in the first few days after balloon placement. Patients may experience stomach cramps, stomach pain or discomfort, nausea, acid reflux with heartburn or indigestion, minor bleeding in the oesophagus, and a feeling of fullness or bloating. To minimise these symptoms, medications are prescribed to control them and should be taken as directed by the doctors and nurses at The BMI Clinic. Less common symptoms that patients may experience include diarrhoea, vomiting, sore throat, excessive salivation, gas or belching, hiccups, constipation, gastrointestinal hypermotility, oesophageal dysmotility, aspiration, hyperventilation, gastritis, halitosis (bad breath), indigestions, or dizziness.
**If any of these symptoms persist or worsen, you should contact The BMI Clinic immediately (including via the 24-hour patient support number on 1300 376 026).

Ulcers – Patients may form an ulcer in the stomach, oesophagus, duodenum and/or intestine due to the intragastric balloon. This may need to be treated with further medication and endoscopy while the balloon is in place. Ulcers may need to be diagnosed, monitored or treated by way of additional endoscopic procedures (under anaesthesia) and early removal of the intragastric balloon may be required.

Dehydration – Dehydration may occur after balloon placement and some patients may need to have intravenous fluids administered

Pancreatitis – The intragastric balloon may cause inflammation of the pancreas. Mild cases of pancreatitis may resolve with or without treatment, but severe cases can cause life-threatening complications. Pancreatitis may require early removal of the intragastric balloon.

Balloon Intolerance – Approximately 5% of patients do not tolerate the intragastric balloon. These patients will experience prolonged nausea, reflux and/or abdominal pain requiring early removal.

Balloon Deflation – Although uncommon, the balloon may deflate at any point after insertion. The deflated balloon will generally pass through the intestines and be expelled with the stool. In rare cases, it can cause an obstruction in the stomach or in the intestines, requiring surgery for removal. The saline used to inflate the balloon is stained with a blue dye, called methylene blue. Should the balloon deflate, you will likely notice that the dye turns your urine blue-green in colour. You may also notice a change in your appetite, or the ability to eat larger amounts of food. If you suspect the balloon has deflated, you should contact the clinic immediately (including by the 24-hour patient support number on 1300 376 026). You will be booked to have the balloon removed endoscopically within 24-48 hours.

Gastrointestinal Injury – The balloon may rub against the stomach causing bleeding, a tear (perforation) or hole. Gastric perforation is a serious complication that occurs in about 1-in-2500 patients. Endoscopy and/or surgery, with removal of the balloon, and repair of the area of bleeding or injury is likely to be required for treatment. Patients with a history of prior gastrointestinal or bariatric surgery are no eligible for an intragastric balloon due to the increased risks of this.

Balloon Removal – The intragastric balloon must be removed after the indicated time-period specified by the balloon manufacturer and by the physician/surgeon. This will require an additional endoscopic procedure for its removal. Complications related to exceeding this period can be serious and life-threatening.

Psychiatric Complications – Although most people experience improvements in their mood with weight loss, some may experience worsening states of depression, which can lead to suicide. Some patients also experience anxiety from the foreign body within their stomach. Patients taking psychiatric medications must disclose this treatment to their physician/surgeon and should have the dosage and effectiveness of these medications monitored carefully by their prescribing physician.